RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "54868-0108-3",
      "PackageDescription": "20 TABLET in 1 BOTTLE, PLASTIC (54868-0108-3)",
      "NDC11Code": "54868-0108-03",
      "ProductNDC": "54868-0108",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metronidazole",
      "NonProprietaryName": "Metronidazole",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19961017",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018764",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "METRONIDAZOLE",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Symptomatic Trichomoniasis. Metronidazole is indicated for the treatment of symptomatic trichomoniasis in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole is indicated in the treatment of asymptomatic females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Consorts. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her consort is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the consort should be treated with metronidazole in cases of reinfection. Amebiasis. Metronidazole is indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, metronidazole therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections. Metronidazole is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole. In the treatment of most serious anaerobic infections, the intravenous form of metronidazole is usually administered initially. This may be followed by oral therapy with metronidazole at the discretion of the physician. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis,B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus niger, and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B . fragilis group, Clostridium species, Peptococcus niger, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and post-surgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus niger, and Peptostreptococcus species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group, and Clostridium species. BONE AND JOINT INFECTIONS, as adjunctive therapy, caused by Bacteroides species including the B. fragilis group. CENTRAL N E RVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATO RY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. ENDOCARDITIS caused by Bacteroides species including the B. fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets and other antibacterial drugs, metronidazole tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Metronidazole is an oral synthetic antiprotozoal and antibacterial agent, 1-(β-hydroxyethyl)-2-methyl-5-nitroimidazole. The structural formula is represented below. Each tablet, for oral administration, contains 250 mg or 500 mg of metronidazole. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydrogenated vegetable oil and microcrystalline cellulose."
    },
    {
      "NDCCode": "54868-0108-1",
      "PackageDescription": "21 TABLET in 1 BOTTLE, PLASTIC (54868-0108-1)",
      "NDC11Code": "54868-0108-01",
      "ProductNDC": "54868-0108",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metronidazole",
      "NonProprietaryName": "Metronidazole",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19961017",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018764",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "METRONIDAZOLE",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Symptomatic Trichomoniasis. Metronidazole is indicated for the treatment of symptomatic trichomoniasis in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole is indicated in the treatment of asymptomatic females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Consorts. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her consort is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the consort should be treated with metronidazole in cases of reinfection. Amebiasis. Metronidazole is indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, metronidazole therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections. Metronidazole is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole. In the treatment of most serious anaerobic infections, the intravenous form of metronidazole is usually administered initially. This may be followed by oral therapy with metronidazole at the discretion of the physician. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis,B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus niger, and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B . fragilis group, Clostridium species, Peptococcus niger, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and post-surgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus niger, and Peptostreptococcus species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group, and Clostridium species. BONE AND JOINT INFECTIONS, as adjunctive therapy, caused by Bacteroides species including the B. fragilis group. CENTRAL N E RVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATO RY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. ENDOCARDITIS caused by Bacteroides species including the B. fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets and other antibacterial drugs, metronidazole tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Metronidazole is an oral synthetic antiprotozoal and antibacterial agent, 1-(β-hydroxyethyl)-2-methyl-5-nitroimidazole. The structural formula is represented below. Each tablet, for oral administration, contains 250 mg or 500 mg of metronidazole. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydrogenated vegetable oil and microcrystalline cellulose."
    },
    {
      "NDCCode": "54868-0108-2",
      "PackageDescription": "10 TABLET in 1 BOTTLE, PLASTIC (54868-0108-2)",
      "NDC11Code": "54868-0108-02",
      "ProductNDC": "54868-0108",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metronidazole",
      "NonProprietaryName": "Metronidazole",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19961017",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018764",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "METRONIDAZOLE",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Symptomatic Trichomoniasis. Metronidazole is indicated for the treatment of symptomatic trichomoniasis in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole is indicated in the treatment of asymptomatic females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Consorts. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her consort is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the consort should be treated with metronidazole in cases of reinfection. Amebiasis. Metronidazole is indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, metronidazole therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections. Metronidazole is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole. In the treatment of most serious anaerobic infections, the intravenous form of metronidazole is usually administered initially. This may be followed by oral therapy with metronidazole at the discretion of the physician. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis,B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus niger, and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B . fragilis group, Clostridium species, Peptococcus niger, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and post-surgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus niger, and Peptostreptococcus species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group, and Clostridium species. BONE AND JOINT INFECTIONS, as adjunctive therapy, caused by Bacteroides species including the B. fragilis group. CENTRAL N E RVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATO RY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. ENDOCARDITIS caused by Bacteroides species including the B. fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets and other antibacterial drugs, metronidazole tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Metronidazole is an oral synthetic antiprotozoal and antibacterial agent, 1-(β-hydroxyethyl)-2-methyl-5-nitroimidazole. The structural formula is represented below. Each tablet, for oral administration, contains 250 mg or 500 mg of metronidazole. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydrogenated vegetable oil and microcrystalline cellulose."
    },
    {
      "NDCCode": "54868-0108-6",
      "PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (54868-0108-6)",
      "NDC11Code": "54868-0108-06",
      "ProductNDC": "54868-0108",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metronidazole",
      "NonProprietaryName": "Metronidazole",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19961017",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018764",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "METRONIDAZOLE",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Symptomatic Trichomoniasis. Metronidazole is indicated for the treatment of symptomatic trichomoniasis in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole is indicated in the treatment of asymptomatic females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Consorts. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her consort is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the consort should be treated with metronidazole in cases of reinfection. Amebiasis. Metronidazole is indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, metronidazole therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections. Metronidazole is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole. In the treatment of most serious anaerobic infections, the intravenous form of metronidazole is usually administered initially. This may be followed by oral therapy with metronidazole at the discretion of the physician. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis,B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus niger, and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B . fragilis group, Clostridium species, Peptococcus niger, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and post-surgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus niger, and Peptostreptococcus species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group, and Clostridium species. BONE AND JOINT INFECTIONS, as adjunctive therapy, caused by Bacteroides species including the B. fragilis group. CENTRAL N E RVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATO RY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. ENDOCARDITIS caused by Bacteroides species including the B. fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets and other antibacterial drugs, metronidazole tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Metronidazole is an oral synthetic antiprotozoal and antibacterial agent, 1-(β-hydroxyethyl)-2-methyl-5-nitroimidazole. The structural formula is represented below. Each tablet, for oral administration, contains 250 mg or 500 mg of metronidazole. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydrogenated vegetable oil and microcrystalline cellulose."
    },
    {
      "NDCCode": "54868-0108-7",
      "PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (54868-0108-7)",
      "NDC11Code": "54868-0108-07",
      "ProductNDC": "54868-0108",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metronidazole",
      "NonProprietaryName": "Metronidazole",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19961017",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018764",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "METRONIDAZOLE",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Symptomatic Trichomoniasis. Metronidazole is indicated for the treatment of symptomatic trichomoniasis in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole is indicated in the treatment of asymptomatic females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Consorts. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her consort is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the consort should be treated with metronidazole in cases of reinfection. Amebiasis. Metronidazole is indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, metronidazole therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections. Metronidazole is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole. In the treatment of most serious anaerobic infections, the intravenous form of metronidazole is usually administered initially. This may be followed by oral therapy with metronidazole at the discretion of the physician. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis,B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus niger, and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B . fragilis group, Clostridium species, Peptococcus niger, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and post-surgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus niger, and Peptostreptococcus species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group, and Clostridium species. BONE AND JOINT INFECTIONS, as adjunctive therapy, caused by Bacteroides species including the B. fragilis group. CENTRAL N E RVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATO RY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. ENDOCARDITIS caused by Bacteroides species including the B. fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets and other antibacterial drugs, metronidazole tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Metronidazole is an oral synthetic antiprotozoal and antibacterial agent, 1-(β-hydroxyethyl)-2-methyl-5-nitroimidazole. The structural formula is represented below. Each tablet, for oral administration, contains 250 mg or 500 mg of metronidazole. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydrogenated vegetable oil and microcrystalline cellulose."
    },
    {
      "NDCCode": "54868-0108-8",
      "PackageDescription": "14 TABLET in 1 BOTTLE, PLASTIC (54868-0108-8)",
      "NDC11Code": "54868-0108-08",
      "ProductNDC": "54868-0108",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metronidazole",
      "NonProprietaryName": "Metronidazole",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19961017",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018764",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "METRONIDAZOLE",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Symptomatic Trichomoniasis. Metronidazole is indicated for the treatment of symptomatic trichomoniasis in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole is indicated in the treatment of asymptomatic females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Consorts. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her consort is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the consort should be treated with metronidazole in cases of reinfection. Amebiasis. Metronidazole is indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, metronidazole therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections. Metronidazole is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole. In the treatment of most serious anaerobic infections, the intravenous form of metronidazole is usually administered initially. This may be followed by oral therapy with metronidazole at the discretion of the physician. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis,B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus niger, and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B . fragilis group, Clostridium species, Peptococcus niger, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and post-surgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus niger, and Peptostreptococcus species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group, and Clostridium species. BONE AND JOINT INFECTIONS, as adjunctive therapy, caused by Bacteroides species including the B. fragilis group. CENTRAL N E RVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATO RY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. ENDOCARDITIS caused by Bacteroides species including the B. fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets and other antibacterial drugs, metronidazole tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Metronidazole is an oral synthetic antiprotozoal and antibacterial agent, 1-(β-hydroxyethyl)-2-methyl-5-nitroimidazole. The structural formula is represented below. Each tablet, for oral administration, contains 250 mg or 500 mg of metronidazole. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydrogenated vegetable oil and microcrystalline cellulose."
    },
    {
      "NDCCode": "15631-0108-3",
      "PackageDescription": "750 PELLET in 1 PACKAGE (15631-0108-3) ",
      "NDC11Code": "15631-0108-03",
      "ProductNDC": "15631-0108",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Carbo Vegetabilis",
      "NonProprietaryName": "Carbo Vegetabilis",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20151006",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
      "SubstanceName": "ACTIVATED CHARCOAL",
      "StrengthNumber": "1",
      "StrengthUnit": "[hp_X]/1",
      "Status": "Active",
      "LastUpdate": "2021-09-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Condition listed above or as directed by the physician."
    },
    {
      "NDCCode": "43596-0108-2",
      "PackageDescription": "1 TUBE in 1 BOX (43596-0108-2)  > 3.4 g in 1 TUBE (43596-0108-1) ",
      "NDC11Code": "43596-0108-02",
      "ProductNDC": "43596-0108",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lbel Concentre Total Labios Global Perfection Spf 20",
      "ProprietaryNameSuffix": "Rouge Amore/red",
      "NonProprietaryName": "Octinoxate And Zinc Oxide",
      "DosageFormName": "LIPSTICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20181019",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Ventura Corporation LTD",
      "SubstanceName": "OCTINOXATE; ZINC OXIDE",
      "StrengthNumber": ".075; .0392",
      "StrengthUnit": "g/g; g/g",
      "Status": "Deprecated",
      "LastUpdate": "2020-12-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20181019",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49288-0108-3",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49288-0108-3)",
      "NDC11Code": "49288-0108-03",
      "ProductNDC": "49288-0108",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Celery",
      "NonProprietaryName": "Celery",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "CELERY",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Dietary Proteins [CS],Vegetable Proteins [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "50332-0108-3",
      "PackageDescription": "20 PACKET in 1 BOX, UNIT-DOSE (50332-0108-3)  > 2 TABLET in 1 PACKET",
      "NDC11Code": "50332-0108-03",
      "ProductNDC": "50332-0108",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cetafen Extra",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19900105",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "HART Health",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Uses: Temporarily relieves minor aches and pains due to: 1 headache, 2 muscular aches, 3 backache, 4 minor arthritis pain, 5 the common cold, 6 toothache, 7 menstrual cramps."
    },
    {
      "NDCCode": "50845-0108-3",
      "PackageDescription": "1 CARTON in 1 CARTON (50845-0108-3)  > 1 BOTTLE, SPRAY in 1 CARTON (50845-0108-2)  > 30 mL in 1 BOTTLE, SPRAY (50845-0108-1)",
      "NDC11Code": "50845-0108-03",
      "ProductNDC": "50845-0108",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Insomnia",
      "NonProprietaryName": "Aquilegia Vulgaris, Avena Sativa, Chamomilla, Coffea Cruda, Cypripedium Pubescens, Humulus Lupulus, Hypericum Perforatum, Kali Phosphoricum,",
      "DosageFormName": "SPRAY",
      "RouteName": "ORAL",
      "StartMarketingDate": "20121204",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Liddell Laboratories, Inc.",
      "SubstanceName": "AQUILEGIA VULGARIS; ARABICA COFFEE BEAN; AVENA SATIVA FLOWERING TOP; CYPRIPEDIUM PARVIFOLUM ROOT; HYPERICUM PERFORATUM; MATRICARIA CHAMOMILLA WHOLE; MELATONIN; MELISSA OFFICINALIS; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; VALERIAN",
      "StrengthNumber": "2; 6; 2; 3; 3; 2; 6; 3; 2; 12; 30; 2",
      "StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL",
      "Status": "Deprecated",
      "LastUpdate": "2015-02-27"
    },
    {
      "NDCCode": "51754-0108-3",
      "PackageDescription": "1000 mL in 1 CASE (51754-0108-3) ",
      "NDC11Code": "51754-0108-03",
      "ProductNDC": "51754-0108",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tranexamic Acid In Sodium Chloride",
      "NonProprietaryName": "Tranexamic Acid",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20190601",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA212020",
      "LabelerName": "Exela Pharma Sciences, LLC",
      "SubstanceName": "TRANEXAMIC ACID",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]",
      "Status": "Active",
      "LastUpdate": "2019-06-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190601",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tranexamic Acid in Sodium Chloride Injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce the risk of hemorrhage during and following tooth extraction.",
      "Description": "Tranexamic acid is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid is a white crystalline powder. The structural formula is. Tranexamic Acid in Sodium Chloride Injection is a clear to colorless sterile, nonpyrogenic injectable solution for intravenous administration. Each IV bag contains 1000 mg tranexamic acid, USP, 700 mg of sodium chloride, USP and Water for Injection, USP. The aqueous solution has a pH of 6.5 to 8.0."
    },
    {
      "NDCCode": "58443-0108-3",
      "PackageDescription": "118 mL in 1 BOTTLE (58443-0108-3) ",
      "NDC11Code": "58443-0108-03",
      "ProductNDC": "58443-0108",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Max Block",
      "ProprietaryNameSuffix": "Spf 30 Sunscreen",
      "NonProprietaryName": "Octinoxate, Octisalate, And Oxybenzone",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130131",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Prime Enterprises, Inc.",
      "SubstanceName": "OCTINOXATE; OCTISALATE; OXYBENZONE",
      "StrengthNumber": "74.25; 49.5; 39.6",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-03-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20130131",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "71335-0108-3",
      "PackageDescription": "20 TABLET in 1 BOTTLE (71335-0108-3) ",
      "NDC11Code": "71335-0108-03",
      "ProductNDC": "71335-0108",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
      "NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120411",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201013",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
      "StrengthNumber": "7.5; 325",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2024-10-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180709",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of, pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings], reserve Hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics). ·         Have not been tolerated, or are not expected to be tolerated. ·         Have not provided adequate analgesia or are not expected to provide adequate analgesia. Hydrocodone bitartrate and acetaminophen tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.",
      "Description": "Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Hydrocodone bitartrate and acetaminophen tablets USP, for oral administration, are available in a variety of strengths as described in the following table. Each hydrocodone bitartrate and acetaminophen tablet contains. In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid. Meets USP Dissolution Test 1."
    },
    {
      "NDCCode": "71584-0108-3",
      "PackageDescription": ".5 g in 1 POUCH (71584-0108-3) ",
      "NDC11Code": "71584-0108-03",
      "ProductNDC": "71584-0108",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Antibacterial Bandages",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "DRESSING",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20180610",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "Guangdong Comfort Medical Products Co., Ltd.",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": ".12",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2025-10-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20211005",
      "SamplePackage": "N",
      "IndicationAndUsage": "First aid to help reduce the risk of infection in minor cuts, scrapes, and burns."
    },
    {
      "NDCCode": "80425-0108-3",
      "PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0108-3) ",
      "NDC11Code": "80425-0108-03",
      "ProductNDC": "80425-0108",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tramadol Hcl",
      "ProprietaryNameSuffix": "Er",
      "NonProprietaryName": "Tramadol Hcl",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140819",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA200503",
      "LabelerName": "Advanced Rx Pharmacy of Tennessee, LLC",
      "SubstanceName": "TRAMADOL HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2024-11-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241120",
      "SamplePackage": "N",
      "IndicationAndUsage": "1 INDICATIONS AND USAGE. Tramadol hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Tramadol hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic.",
      "Description": "Tramadol hydrochloride is an opioid agonist in an extended-release tablet formulation for oral use. The chemical name is (±) cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol HCl is 299.84. It is a white, bitter, crystalline and odorless powder that is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride extended-release tablets USP contain 100, 200 or 300 mg of tramadol HCl in an extended-release formulation. The tablets are white to off-white in color and contain the inactive ingredients: colloidal silicon dioxide, dibutyl sebacate, ethyl cellulose, microcrystalline cellulose, povidone, and sodium stearyl fumarate. The imprinting ink contains shellac, iron oxide black and propylene glycol. Tramadol hydrochloride extended-release tablets USP meet USP Dissolution Test 3."
    },
    {
      "NDCCode": "54868-0018-3",
      "PackageDescription": "20 TABLET in 1 BOTTLE (54868-0018-3)",
      "NDC11Code": "54868-0018-03",
      "ProductNDC": "54868-0018",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Erythromycin Ethylsuccinate",
      "NonProprietaryName": "Erythromycin Ethylsuccinate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19960227",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA061904",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "ERYTHROMYCIN ETHYLSUCCINATE",
      "StrengthNumber": "400",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.",
      "Description": "Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate."
    },
    {
      "NDCCode": "54868-0021-3",
      "PackageDescription": "120 TABLET in 1 BOTTLE, PLASTIC (54868-0021-3)",
      "NDC11Code": "54868-0021-03",
      "ProductNDC": "54868-0021",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sulfamethoxazole And Trimethoprim",
      "NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19950811",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090624",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
      "StrengthNumber": "800; 160",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "54868-0023-3",
      "PackageDescription": "500 CAPSULE in 1 BOTTLE (54868-0023-3)",
      "NDC11Code": "54868-0023-03",
      "ProductNDC": "54868-0023",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Doxycycline Hyclate",
      "NonProprietaryName": "Doxycycline Hyclate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19930611",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA062031",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "DOXYCYCLINE HYCLATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-19"
    },
    {
      "NDCCode": "54868-0024-3",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (54868-0024-3)",
      "NDC11Code": "54868-0024-03",
      "ProductNDC": "54868-0024",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tetracycline Hydrochloride",
      "NonProprietaryName": "Tetracycline Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19880301",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA060704",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "TETRACYCLINE HYDROCHLORIDE",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: 1 Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. , 2 Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.), 3 Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.), 4 Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox., 5 Psittacosis or ornithosis caused by Chlamydia Psittaci., 6 Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum., 7 Granuloma inquinale caused by Calymmatobacterium granulomatis., 8 Relapsing fever caused by Borrelia sp., 9 Bartonellosis caused by Bartonella bacilliformis., 10 Chancroid caused by Hemophilus ducreyi., 11 Tularemia caused by Francisella tularensis., 12 Plaque caused by Yersinia pestis., 13 Cholera caused by Vibrio cholerae., 14 Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside)., 15 Infections due to Campylobacter fetus., 16 As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica., 17 Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc., 18 Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp., 19 In severe acne, adjunctive therapy with tetracycline may be useful.",
      "Description": "Tetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-boxamide monohydrochloride. Its structural formula is as follows. C22H24N208HCI M.W. 480.90. Each capsule, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, pregelatinized starch and stearic acid. The inactive ingredients for the gelatin capsules include: (250 mg) FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide; (500 mg): FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No. 10, and titanium dioxide."
    },
    {
      "NDCCode": "54868-0025-3",
      "PackageDescription": "40 CAPSULE in 1 BOTTLE (54868-0025-3)",
      "NDC11Code": "54868-0025-03",
      "ProductNDC": "54868-0025",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tetracycline Hydrochloride",
      "NonProprietaryName": "Tetracycline Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19961009",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA060704",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "TETRACYCLINE HYDROCHLORIDE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: 1 Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. , 2 Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.), 3 Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.), 4 Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox., 5 Psittacosis or ornithosis caused by Chlamydia Psittaci., 6 Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum., 7 Granuloma inquinale caused by Calymmatobacterium granulomatis., 8 Relapsing fever caused by Borrelia sp., 9 Bartonellosis caused by Bartonella bacilliformis., 10 Chancroid caused by Hemophilus ducreyi., 11 Tularemia caused by Francisella tularensis., 12 Plaque caused by Yersinia pestis., 13 Cholera caused by Vibrio cholerae., 14 Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside)., 15 Infections due to Campylobacter fetus., 16 As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica., 17 Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc., 18 Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp., 19 In severe acne, adjunctive therapy with tetracycline may be useful.",
      "Description": "Tetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-boxamide monohydrochloride. Its structural formula is as follows. C22H24N208HCI M.W. 480.90. Each capsule, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, pregelatinized starch and stearic acid. The inactive ingredients for the gelatin capsules include: (250 mg) FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide; (500 mg): FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No. 10, and titanium dioxide."
    },
    {
      "NDCCode": "54868-0032-3",
      "PackageDescription": "20 TABLET in 1 BOTTLE, PLASTIC (54868-0032-3)",
      "NDC11Code": "54868-0032-03",
      "ProductNDC": "54868-0032",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diphenoxylate Hydrochloride And Atropine Sulfate",
      "NonProprietaryName": "Diphenoxylate Hydrochloride And Atropine Sulfate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19950127",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA085762",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE",
      "StrengthNumber": "2.5; .025",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]",
      "DEASchedule": "CV",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Diphenoxylate hydrochloride and atropine sulfate tablets are effective as adjunctive therapy in the management of diarrhea.",
      "Description": "Each tablet for oral administration contains. diphenoxylatehydrochloride, USP 2.5 mg(Warning – May be habit forming). atropinesulfate, USP 0.025 mg. Diphenoxylate hydrochloride, an antidiarrheal, is ethyl 1-(3-cyano-3, 3-diphenylpropyl)-4-phenyl-isonipecotate monohydrochloride and has the following structure. Atropine sulfate, an anticholinergic, is endo-(±)-alpha-(hydroxymethyl) benzeneacetic acid 8-methyl-8-azabicylo[3.2.1] oct-3-yl ester sulfate (2:1)] (salt) monohydrate and has the following structure. A subtherapeutic amount of atropine sulfate is present to discourage deliberate overdosage. Each tablet for oral administration contains the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch and stearic acid."
    },
    {
      "NDCCode": "54868-0033-3",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (54868-0033-3)",
      "NDC11Code": "54868-0033-03",
      "ProductNDC": "54868-0033",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dicyclomine Hydrochloride",
      "NonProprietaryName": "Dicyclomine Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19951026",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA084285",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "DICYCLOMINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Dicyclomine hydrochloride tablets and capsules are indicated for the treatment of functional bowel/ irritable bowel syndrome.",
      "Description": "Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following forms. 1. Dicyclomine Hydrochloride Tablets USP, for oral administration, contain 20 mg dicyclomine hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: acacia, pregelatinized starch, anhydrous lactose, compressible sugar, dicalcium phosphate, colloidal silicon dioxide, magnesium stearate, stearic acid, and FD & C Blue #1 Aluminum Lake. 2. Dicyclomine Hydrochloride Capsules USP, for oral administration, contain 10 mg of dicyclomine hydrochloride, USP. In addition, each capsule contains the following inactive ingredients: lactose monohydrate, calcium sulfate, magnesium stearate; and the capsules shells contain: gelatin, FD&C Blue # 1, and FD&C Red # 3. Chemically, dicyclomine hydrochloride is 2-(Diethylamino)ethyl [bicyclohexyl]-1-carboxylate hydrochloride with the structural formula. Dicyclomine hydrochloride occurs as a fine, white, crystalline, practically odorless powder with a bitter taste. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether."
    },
    {
      "NDCCode": "54868-0034-3",
      "PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (54868-0034-3)",
      "NDC11Code": "54868-0034-03",
      "ProductNDC": "54868-0034",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metoclopramide",
      "NonProprietaryName": "Metoclopramide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20030501",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078807",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "METOCLOPRAMIDE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "The use of metoclopramide tablets is recommended for adults only. Therapy should not exceed 12 weeks in duration. Metoclopramide tablets are indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy. The principal effect of metoclopramide is on symptoms of postprandial and daytime heartburn with less observed effect on nocturnal symptoms. If symptoms are confined to particular situations, such as following the evening meal, use of metoclopramide as single doses prior to the provocative situation should be considered, rather than using the drug throughout the day. Healing of esophageal ulcers and erosions has been endoscopically demonstrated at the end of a 12-week trial using doses of 15 mg q.i.d. As there is no documented correlation between symptoms and healing of esophageal lesions, patients with documented lesions should be monitored endoscopically. Metoclopramide tablets, are indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis. The usual manifestations of delayed gastric emptying (e.g., nausea, vomiting, heartburn, persistent fullness after meals, and anorexia) appear to respond to metoclopramide tablets within different time intervals. Significant relief of nausea occurs early and continues to improve over a three-week period. Relief of vomiting and anorexia may precede the relief of abdominal fullness by one week or more.",
      "Description": "For oral administration, Metoclopramide tablets, USP 10 mg are white to off white, capsule shaped, biconvex tablets with \"RF11\" embossed on one side and score line on the other side. Each tablet contains. 10 mg of metoclopramide base as metoclopramide hydrochloride USP."
    },
    {
      "NDCCode": "54868-0038-3",
      "PackageDescription": "20 CAPSULE in 1 BOTTLE (54868-0038-3)",
      "NDC11Code": "54868-0038-03",
      "ProductNDC": "54868-0038",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Temazepam",
      "NonProprietaryName": "Temazepam",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20080110",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070920",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "TEMAZEPAM",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Temazepam is indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that temazepam should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.",
      "Description": "Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. Its structural formula may be represented as follows. C16H13ClN2O2               M.W. = 300.74. Temazepam, USP is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol. Temazepam capsules, 15 mg, 22.5 mg and 30 mg, are for oral administration. Each capsule contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, powdered cellulose and sodium lauryl sulfate."
    },
    {
      "NDCCode": "54868-0039-3",
      "PackageDescription": "20 CAPSULE in 1 BOTTLE (54868-0039-3)",
      "NDC11Code": "54868-0039-03",
      "ProductNDC": "54868-0039",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Temazepam",
      "NonProprietaryName": "Temazepam",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20050111",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070920",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "TEMAZEPAM",
      "StrengthNumber": "30",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Temazepam is indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that temazepam should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.",
      "Description": "Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. Its structural formula may be represented as follows. C16H13ClN2O2               M.W. = 300.74. Temazepam, USP is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol. Temazepam capsules, 15 mg, 22.5 mg and 30 mg, are for oral administration. Each capsule contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, powdered cellulose and sodium lauryl sulfate."
    },
    {
      "NDCCode": "54868-0043-3",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (54868-0043-3)",
      "NDC11Code": "54868-0043-03",
      "ProductNDC": "54868-0043",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dipyridamole",
      "NonProprietaryName": "Dipyridamole",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20080905",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA089000",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "DIPYRIDAMOLE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-19"
    },
    {
      "NDCCode": "54868-0048-3",
      "PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (54868-0048-3)",
      "NDC11Code": "54868-0048-03",
      "ProductNDC": "54868-0048",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clonidine Hydrochloride",
      "NonProprietaryName": "Clonidine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20011003",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070925",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "CLONIDINE HYDROCHLORIDE",
      "StrengthNumber": ".1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Clonidine hydrochloride USP tablets are indicated in the treatment of hypertension. Clonidine hydrochloride USP tablets may be employed alone or concomitantly with other antihypertensive agents.",
      "Description": "Clonidine hydrochloride USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. Clonidine hydrochloride tablets contain the following inactive ingredients: lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. The 0.1 mg also contains D&C yellow #10 aluminum lake, and the 0.3 mg contains D&C yellow #10 aluminum lake and FD&C blue #1 aluminum lake. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol."
    },
    {
      "NDCCode": "54868-0050-3",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (54868-0050-3)",
      "NDC11Code": "54868-0050-03",
      "ProductNDC": "54868-0050",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methyldopa",
      "NonProprietaryName": "Methyldopa",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19950829",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070098",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "METHYLDOPA",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Hypertension.",
      "Description": "Methyldopa USP is an antihypertensive drug. Methyldopa USP is the L-isomer of alpha-methyldopa. Its chemical name is levo-3-(3,4-dihydroxyphenyl)- 2-methylalanine sesquihydrate. Its structural formula is. C 10H13NO4  1 1/2 H2O M.W. 238.24. Methyldopa USP is a white to yellowish white, odorless fine powder and is sparingly soluble in water. Each tablet, for oral administration, contains 250 mg or 500 mg of methyldopa USP. Potency is calculated in the anhydrous basis. Inactive ingredients: citric acid, colloidal silicon dioxide, edetate disodium, ethylcellulose, hypromellose, magnesium stearate, methylcellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. In addition, the 250 mg tablet contains calcium sulfate, hydroxypropyl cellulose, and talc, and the 500 mg tablet contains polysorbate 80."
    },
    {
      "NDCCode": "54868-0053-3",
      "PackageDescription": "100 TABLET in 1 BOTTLE (54868-0053-3)",
      "NDC11Code": "54868-0053-03",
      "ProductNDC": "54868-0053",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Propranolol Hydrochloride",
      "NonProprietaryName": "Propranolol Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19961209",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078955",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Propranolol hydrochloride tablets are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets are not indicated in the management of hypertensive emergencies. Propranolol hydrochloride tablets are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Propranolol hydrochloride tablets are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response. Propranolol hydrochloride tablets are indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable. Propranolol hydrochloride tablets are indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use. Propranolol hydrochloride tablets are indicated in the management of familial or hereditary essential tremor. Familial or essential tremor consists of involuntary, rhythmic, oscillatory movements, usually limited to the upper limbs. It is absent at rest, but occurs when the limb is held in a fixed posture or position against gravity and during active movement. Propranolol hydrochloride tablets, USP causes a reduction in the tremor amplitude but not in the tremor frequency. Propranolol hydrochloride tablets are not indicated for the treatment of tremor associated with Parkinsonism. Propranolol hydrochloride tablets improve NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis. Propranolol hydrochloride tablets are indicated as an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors.",
      "Description": "hydrochloride(Propranolol is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It’s molecular and structural formulae are. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and in ethanol. Its molecular weight is 295.80. Propranolol hydrochloride tablets, USP are available as 10 mg, 20 mg, 40 mg, 60 mg, and 80 mg tablets for oral administration. The inactive ingredients contained in propranolol hydrochloride tablets, USP are: lactose monohydrate, corn starch, sodium starch glycolate, magnesium stearate, and povidone. In addition, propranolol hydrochloride tablets, USP 10 mg, 40 mg and 80 mg contain FD &C yellow No.6 Aluminium Lake and Color D&C Yellow No. 10; propranolol hydrochloride tablets, USP 20 mg and 40mg contain FD&C Blue No.1 and propranolol hydrochloride tablets, USP 60 mg contain D&C Red No. 30 Lake."
    }
  ]
}
                    

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